1. Technical Field
The present disclosure relates to methods and apparatus for conducting ultrasound examination and biopsy of biological tissue. More specifically, the present disclosure provides apparatus and methods for securing biological tissue while permitting ready access to perform a biopsy guided by a real-time ultrasound image of the tissue.
2. Background of Related Art
A number of previously known devices have been developed to permit image-guided biopsy of biological tissue. Such systems recognize that to perform an effective biopsy less-invasively, the clinician must be able to guide the biopsy instrument to a suspected lesion with high accuracy. Without visual confirmation that the biopsy instrument has indeed excised a portion of the suspected lesion, the risk exists that the biopsy may have excised only a portion of healthy tissue, thereby leading to misdiagnosis.
Many of the previously known systems have been unsuitable for performing real-time, image guided biopsy. Such systems, as described, for example, in U.S. Pat. No. 3,765,403 to Brenden and U.S. Pat. No. 3,963,933 to Henkes, Jr., require the patient to lay prone and insert her breast into a water-filled bath. There is no capability in such systems to position and insert a biopsy instrument into the breast while it is immersed in the water bath. Likewise, ultrasound scanning systems such as described in U.S. Pat. No. 4,433,690 to Green et al. and U.S. Pat. No. 4,434,799 to Taenzer, in which the patient's tissue is almost entirely enclosed within the apparatus, offer no capability to perform real-time, image guided biopsy.
Needle guides, which are attached to an ultrasound scanning device, such as described in U.S. Pat. No. 4,058,114 to Soldner, provide aiming of a biopsy needle into tissue using real-time ultrasound images. Such devices, however, constrain the biopsy needle to be in a fixed relation to the ultrasound transducer, may be cumbersome to use, and are not suitable for larger biopsy devices.
U.S. Pat. No. 5,660,185 to Shmulewitz et al. and U.S. Pat. No. 5,664,573 to Shmulewitz describe ultrasound imaging and biopsy systems that have advanced the state of the art by providing the capability to perform real-time, image-guided biopsy of breast tissue. These devices, however, only provide access to the patient's tissue either through the space between the upper and lower compression plates, or through a grid-style compression plate.
In view of the foregoing, it would be desirable to provide ultrasound scanning and biopsy apparatus that permits increased access to the patient's tissue to perform real-time, image-guided biopsy compared to previously known systems.
A further drawback of previously known devices is that steps must be taken to sterilize and clean the equipment after each biopsy. Accordingly, it further would be desirable to provide ultrasound scanning systems that employ disposable components, so that portions of the system that contact patient's blood during an examination may be readily sterilized or discarded.